Circular stapling instrument with firing trigger having integral resilient features

ABSTRACT

An apparatus includes a body assembly, an end effector, and a firing assembly. The body includes a handle portion and a shaft portion. The end effector includes a staple driver. The firing assembly includes a driver actuator and a trigger. The driver actuator is configured to actuate the staple driver. The driver actuator is slidably housed within the shaft portion. The trigger includes a lever and an integral spring member. The lever is pivotally coupled to the handle portion via a pivot boss of the handle portion. The trigger is configured to pivot between a first position and a second position to slide the driver actuator within the shaft portion, to thereby actuate the staple driver. The integral spring member is at least partially housed within a spring channel of the handle portion and is configured to resiliently bias the trigger toward the first position.

BACKGROUND

In some surgical procedures (e.g., colorectal, bariatric, thoracic,etc.), portions of a patient's digestive tract (e.g., thegastrointestinal tract and/or esophagus, etc.) may be cut and removed toeliminate undesirable tissue or for other reasons. Once the tissue isremoved, the remaining portions of the digestive tract may be coupledtogether in an end-to-end anastomosis. The end-to-end anastomosis mayprovide a substantially unobstructed flow path from one portion of thedigestive tract to the other portion of the digestive tract, withoutalso providing any kind of leaking at the site of the anastomosis.

One example of an instrument that may be used to provide an end-to-endanastomosis is a circular stapler. Some such staplers are operable toclamp down on layers of tissue, cut through the clamped layers oftissue, and drive staples through the clamped layers of tissue tosubstantially seal the layers of tissue together near the severed endsof the tissue layers, thereby joining the two severed ends of theanatomical lumen together. The circular stapler may be configured tosever the tissue and seal the tissue substantially simultaneously. Forinstance, the circular stapler may sever excess tissue that is interiorto an annular array of staples at an anastomosis, to provide asubstantially smooth transition between the anatomical lumen sectionsthat are joined at the anastomosis. Circular staplers may be used inopen procedures or in endoscopic procedures. In some instances, aportion of the circular stapler is inserted through a patient'snaturally occurring orifice.

Examples of circular staplers are described in U.S. Pat. No. 5,205,459,entitled “Surgical Anastomosis Stapling Instrument,” issued Apr. 27,1993; U.S. Pat. No. 5,271,544, entitled “Surgical Anastomosis StaplingInstrument,” issued Dec. 21, 1993; U.S. Pat. No. 5,275,322, entitled“Surgical Anastomosis Stapling Instrument,” issued Jan. 4, 1994; U.S.Pat. No. 5,285,945, entitled “Surgical Anastomosis Stapling Instrument,”issued Feb. 15, 1994; U.S. Pat. No. 5,292,053, entitled “SurgicalAnastomosis Stapling Instrument,” issued Mar. 8, 1994; U.S. Pat. No.5,333,773, entitled “Surgical Anastomosis Stapling Instrument,” issuedAug. 2, 1994; U.S. Pat. No. 5,350,104, entitled “Surgical AnastomosisStapling Instrument,” issued Sep. 27, 1994; and U.S. Pat. No. 5,533,661,entitled “Surgical Anastomosis Stapling Instrument,” issued Jul. 9,1996; and U.S. Pat. No. 8,910,847, entitled “Low Cost Anvil Assembly fora Circular Stapler,” issued Dec. 16, 2014. The disclosure of each of theabove-cited U.S. patents is incorporated by reference herein.

While various kinds of surgical stapling instruments and associatedcomponents have been made and used, it is believed that no one prior tothe inventor(s) has made or used the invention described in the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim this technology, it is believed this technologywill be better understood from the following description of certainexamples taken in conjunction with the accompanying drawings, in whichlike reference numerals identify the same elements and in which:

FIG. 1 depicts a side elevation view of an exemplary circular staplingsurgical instrument;

FIG. 2 depicts a perspective view of an exemplary anvil of the surgicalinstrument of FIG. 1;

FIG. 3 depicts another perspective view of the anvil of FIG. 2;

FIG. 4 depicts an exploded side elevational view of the anvil of FIG. 2;

FIG. 5 depicts a perspective view of a stapling head assembly of thesurgical instrument of FIG. 1;

FIG. 6 depicts an exploded perspective view of the stapling headassembly of FIG. 5;

FIG. 7A depicts an enlarged side elevation view of an exemplary actuatorhandle assembly of the surgical instrument of FIG. 1 with a portion ofthe body removed, showing a trigger in an unfired position and a lockoutfeature in a locked position;

FIG. 7B depicts an enlarged side elevation view of the actuator handleassembly of FIG. 7A, showing the trigger in a fired position and thelockout feature in an unlocked position;

FIG. 8 depicts an enlarged partial perspective view of an exemplaryindicator assembly of the surgical instrument of FIG. 1, showing anindicator window and indicator lever;

FIG. 9 depicts a diagrammatic view of the indicator window of FIG. 10,showing an exemplary indicator bar and exemplary corresponding staplerepresentations;

FIG. 10A depicts an enlarged longitudinal cross-section view of thestapling head assembly of FIG. 5, showing the anvil of FIG. 2 in a firstopen position, where the anvil is within a first tubular portion oftissue and the stapling head assembly is within a second tubular portionof tissue;

FIG. 10B depicts an enlarged longitudinal cross-sectional view of thestapling head assembly of FIG. 5, showing the anvil of FIG. 2 in aclosed position, where the anvil is within the first tubular portion oftissue and the stapling head assembly is within the second tubularportion of tissue;

FIG. 10C depicts an enlarged longitudinal cross-sectional view of thestapling head assembly of FIG. 5, showing the anvil of FIG. 2 in theclosed position, were an exemplary staple driver and blade are in afired position such that the first tubular portion of tissue and thesecond tubular portion of tissue are stapled together with excess tissuesevered;

FIG. 10D depicts an enlarged longitudinal cross-sectional view of thestapling head assembly of FIG. 5, showing the anvil of FIG. 2 in asecond open position, where the first tubular portion of tissue and thesecond tubular portion of tissue are attached;

FIG. 10E depicts an enlarged longitudinal cross-section view of thefirst tubular portion and the second tubular portion after the staplinghead assembly of FIG. 5 and the anvil of FIG. 2 have been removed,leaving a completed end-to-end anastomosis;

FIG. 11 depicts an enlarged partial cross-sectional view of an exemplarystaple formed against the anvil of FIG. 2;

FIG. 12 depicts a perspective view of an exemplary alternative circularstapling surgical instrument;

FIG. 13 depicts an exploded perspective view of the surgical instrumentof FIG. 12;

FIG. 14 depicts a perspective view of a closure system of the surgicalinstrument of FIG. 12;

FIG. 15 depicts an exploded perspective view of the closure system ofFIG. 14;

FIG. 16 depicts a perspective view of a trigger of the closure assemblyof FIG. 14;

FIG. 17 depicts another perspective view of the trigger of FIG. 16;

FIG. 18 depicts a bottom plan view of the trigger of FIG. 16;

FIG. 19 depicts a side elevation view of the trigger of FIG. 16;

FIG. 20 depicts a perspective view of a first portion of a casingassembly of the surgical instrument of FIG. 12;

FIG. 21A depicts an enlarged side elevation view of a handle portion ofthe surgical instrument of FIG. 12, with a portion of the body removed,showing the trigger of FIG. 16 in an unfired position and a lockoutfeature in a locked position;

FIG. 21B depicts an enlarged side elevation view of the handle portionof FIG. 21A, with a portion of the body removed, showing the trigger ina fired position and the lockout feature in an unlocked position; and

FIG. 21C depicts an enlarged side elevation view of the handle portionof FIG. 21A, with a portion of the body removed, showing the triggerbiased from the fired position to the unfired position and the lockoutfeature in an unlocked position.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the technology may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presenttechnology, and together with the description serve to explain theprinciples of the technology; it being understood, however, that thistechnology is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Circular Stapling Surgical Instrument

FIGS. 1-11 depict an exemplary circular surgical stapling instrument(10) having a stapling head assembly (200), a shaft assembly (60), andan actuator handle assembly (70), each of which will be described inmore detail below. Shaft assembly (60) extends distally from actuatorhandle assembly (70) and stapling head assembly (200) is coupled to adistal end of shaft assembly (60). In brief, actuator handle assembly(70) is operable to actuate a staple driver member (250) of staplinghead assembly (200) to drive a plurality of staples (66) out of staplinghead assembly (200). Staples (66) are bent to form completed staples byan anvil (40) that is selectively attached at the distal end ofinstrument (10). Accordingly, tissue (2), as shown in FIGS. 10A-10E, maybe stapled utilizing instrument (10).

In the present example, instrument (10) comprises a closure system and afiring system. As will be described in greater detail below, the closuresystem and anvil (40) are operable to clamp tissue between anvil (40)and stapling head assembly (200). As will also be described in greaterdetail below, the firing system and anvil (40) are operable to cut andstaple tissue clamped between anvil (40) and stapling head assembly(200).

The closure system comprises a trocar (230), a trocar actuator (231),and an adjustment knob (98). Anvil (40) may be coupled to a distal endof trocar (230). Adjustment knob (98) is operable to longitudinallytranslate trocar (230) relative to stapling head assembly (200), therebytranslating anvil (40) when anvil (40) is suitably coupled to trocar(230), and further clamping tissue between anvil (40) and stapling headassembly (200) as will be described in greater detail below.

The firing system comprises a trigger (74), a trigger actuation assembly(84), a driver actuator (64), and a staple driver member (250). Stapledriver member (250) includes a knife member (240) configured to severtissue when staple driver member (250) is actuated longitudinally. Inaddition, staples (66) are positioned distal to a plurality of stapledrivers of staple driver member (250) such that staple driver member(250) also drives staples (66) distally when staple driver member (250)is actuated longitudinally. Thus, when trigger (74) is actuated andtrigger actuation assembly (84) actuates staple driver member (250) viadriver actuator (64), knife member (240) and staple drivers (252)substantially simultaneously sever tissue (2) and drive staples (66)distally relative to stapling head assembly (200) into tissue. Thecomponents and functionalities of the closure system and firing systemwill now be described in greater detail.

A. Exemplary Anvil

In the following discussion of anvil (40), the terms “distal” and“proximal” (and variations thereof) will be used with reference to theorientation of anvil (40) when anvil (40) is coupled with shaft assembly(60) of instrument (10). Thus, proximal features of anvil (40) will becloser to the operator of instrument (10); while distal features ofanvil (40) will be further from the operator of instrument (10).

As best seen in FIGS. 2-4, anvil (40) of the present example comprises ahead (48) and a proximal shaft (44). As mentioned above and as will bedescribed in greater detail below, anvil (40) of the present example mayselectively couple to trocar (230) such that when coupled, movement oftrocar (230) relative to stapling head assembly (200) also moves anvil(40) relative to stapling head assembly (200).

Head (48) includes a proximal surface (50) that defines a plurality ofstaple forming pockets (52). Staple forming pockets (52) are arranged intwo concentric annular arrays. In some other versions, staple formingpockets (52) are arranged in three or more concentric annular arrays.Staple forming pockets (52) are configured to deform staples as thestaples are driven into staple forming pockets (52). Accordingly, whenanvil (40) is in the closed position and staples (66) are driven out ofstapling head assembly (200) into staple forming pockets (52), eachstaple forming pocket (52) may deform a generally “U” shaped staple (66)into a “B” shape as is known in the art. As best seen in FIG. 4,proximal surface (50) terminates at an inner edge (54), which defines anouter boundary of an annular recess (56) surrounding proximal shaft(44).

Proximal shaft (44) defines a bore (46) and includes a pair of pivotinglatch members (30) positioned in bore (46). As best seen in FIG. 4, eachlatch member (30) includes a “T” shaped distal end (32), a roundedproximal end (34), and a latch shelf (36) located distal to proximal end(34). “T” shaped distal ends (32) secure latch members (30) within bore(46). Latch members (30) are positioned within bore (46) such thatdistal ends (34) are positioned at the proximal ends of lateral openings(42), which are formed through the sidewall of proximal shaft (44).Lateral openings (42) thus provide clearance for distal ends (34) andlatch shelves (36) to deflect radially outwardly from the longitudinalaxis defined by proximal shaft (44). However, latch members (30) areconfigured to resiliently bias distal ends (34) and latch shelves (36)radially inwardly toward the longitudinal axis defined by proximal shaft(44). Latch members (30) thus act as retaining clip to allow anvil (40)to be selectively secured to trocar (230) of stapling head assembly(200). It should be understood, however, that latch members (36) aremerely optional. Anvil (40) may be removably secured to a trocar (230)using any other suitable components, features, or techniques.

In addition to or in lieu of the foregoing, anvil (40) may be furtherconstructed and operable in accordance with at least some of theteachings of U.S. Pat. Nos. 5,205,459; 5,271,544; 5,275,322; 5,285,945;5,292,053; 5,333,773; 5,350,104; 5,533,661; 8,910,847; U.S. Pub. No,2016/037471; and/or U.S. Pub. No. 2016/0374684, the disclosures of whichare incorporated by reference herein. Still other suitableconfigurations will be apparent to one of ordinary skill in the art inview of the teachings herein.

B. Exemplary Stapling Head Assembly

As best seen in FIGS. 5-6, stapling head assembly (200) of the presentexample is coupled to a distal end of shaft assembly (60) and comprisesa tubular casing (210) housing a slidable staple driver member (250). Acylindraceous inner core member extends distally within tubular casing(210). Tubular casing (210) is fixedly secured to an outer sheath (62)of shaft assembly (60), such that tubular casing (210) serves as amechanical ground for stapling head assembly (200).

Trocar (230) is positioned coaxially within inner core member (212) oftubular casing (210). As mentioned above and as will be described ingreater detail below, trocar (230) is operable to translate distally andproximally relative to tubular casing (210) in response to rotation ofadjustment knob (98) relative to casing (110) of handle assembly (100).Trocar (230) comprises a shaft (232) and a head (234). Head (234)includes a pointed tip (236) and an inwardly extending proximal surface(238). Shaft (232) thus provides a reduced outer diameter just proximalto head (234), with surface (238) providing a transition between thatreduced outer diameter of shaft (232) and the outer diameter of head(234). While tip (236) is pointed in the present example, tip (236) isnot sharp. Tip (236) will thus not easily cause trauma to tissue due toinadvertent contact with tissue. Head (234) and the distal portion ofshaft (232) are configured for insertion in bore (46) of anvil (40).Proximal surface (238) and latch shelves (36) have complementarypositions and configurations such that latch shelves (36) engageproximal surface (238) when proximal shaft (44) of anvil (40) is fullyseated on trocar (230). Anvil (40) may thus secure to trocar (230)through a snap fitting between latch members (30) and head (234). Inaddition, or in the alternative, trocar (230) may include a magneticportion (not shown) which may attract anvil (40) towards trocar (230).Still further configurations and arrangements for anvil (40) and trocar(230) will be apparent to one of ordinary skill in the art in view ofthe teachings herein.

Staple driver member (250) is operable to actuate longitudinally withintubular casing (210) in response to rotation of trigger (74) of actuatorhandle assembly (70) as will be described in greater detail below.Staple driver member (250) includes two distally presented concentricannular arrays of staple drivers (252). Staple drivers (252) arearranged to correspond with the arrangement of staple forming pockets(52) described above. As best seen in FIGS. 10A-10B, each staple driver(252) is located underneath a corresponding staple (66). The arrangementof staple drivers (252) may be modified just like the arrangement ofstaple forming pockets (52) as described above. Staple driver member(250) also defines a bore (254) that is configured to coaxially receivecore member (212) of tubular casing (210). An annular array of studs(256) project distally from a distally presented surface surroundingbore (254).

A cylindraceous knife member (240) is coaxially positioned within stapledriver member (250). Knife member (240) includes a distally presented,sharp circular cutting edge (242). Knife member (240) is sized such thatknife member (240) defines an outer diameter that is smaller than thediameter defined by the inner annular array of staple drivers (252).Knife member (240) also defines an opening that is configured tocoaxially receive core member (212) of tubular casing (210). An annulararray of openings (246) formed in knife member (240) is configured tocomplement the annular array of studs (256) of staple driver member(250), such that knife member (240) is fixedly secured to staple drivermember (250) via studs (256) and openings (346). Therefore, whenstapling driver member (250) is actuated relative to tubular casing(210), so is knife member (240). Other suitable structural relationshipsbetween knife member (240) and stapler driver member (250) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

A deck member (220) is fixedly secured to tubular casing (210). Deckmember (220) includes a distally presented deck surface (222) definingtwo concentric annular arrays of staple openings (224), where eachstaple opening (224) has its own staple pocket (226) housing a staple(66). Staple openings (224) and staple pockets (226) are arranged tocorrespond with the arrangement of staple drivers (252) and stapleforming pockets (52) described above. Accordingly, when staple drivermember (250) is actuated distally relative to tubular casing (210) inresponse to rotation of trigger (74), each staple driver (252) drives acorresponding staple (66) out of its staple pocket (226) and through acorresponding staple opening (224) of deck member (220). When anvil (40)is in the closed position, staples (66) are driven into a correspondingstaple forming pockets (52) to bend legs (68) of the staples (66),thereby stapling the material located between anvil (40) and staplinghead assembly (200).

The arrangement of staple openings (224) may be modified just like thearrangement of staple forming pockets (52) as described above. It shouldalso be understood that various structures and techniques may be used tocontain staples (66) within stapling head assembly (200) before staplinghead assembly (200) is actuated. Such structures and techniques that areused to contain staples within stapling head assembly (200) may preventthe staples from inadvertently falling out through staple openings (224)before stapling head assembly (200) is actuated. Various suitable formsthat such structures and techniques may take will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

As best seen in FIG. 6, deck member (220) defines an inner diameter thatis just slightly larger than the outer diameter defined by knife member(240). Deck member (220) is thus configured to allow knife member (240)to translate distally to a point where cutting edge (242) is distal todeck surface (222).

In addition to or in lieu of the foregoing, stapling head assembly (200)may be further constructed and operable in accordance with at least someof the teachings of U.S. Pat. Nos. 5,205,459; 5,271,544; 5,275,322;5,285,945; 5,292,053; 5,333,773; 5,350,104; 5,533,661; 8,910,847; U.S.Pub. No, 2016/037471; and/or U.S. Pub. No. 2016/0374684, the disclosuresof which are incorporated by reference herein. Still other suitableconfigurations will be apparent to one of ordinary skill in the art inview of the teachings herein.

C. Exemplary Shaft Assembly

Stapling head assembly (200) and trocar (230) are positioned at a distalend of shaft assembly (60), as shown in FIGS. 10A-10D. Shaft assembly(60) of the present example comprises an outer tubular member (62) and adriver actuator (64). Outer tubular member (62) is coupled to tubularcasing (210) of stapling head assembly (200) and to a body (72) ofactuator handle assembly (70), thereby providing a mechanical ground forthe actuating components therein. As seen in FIGS. 7A-7B, the proximalend of driver actuator (64) is coupled to a trigger actuation assembly(84) of actuator handle assembly (70), as described below. The distalend of driver actuator (64) is coupled to staple driver member (250)such that the rotation of trigger (74) longitudinally actuates stapledriver member (250). As shown in FIGS. 10A-10D, driver actuator (64)comprises a tubular member having an open longitudinal axis such thattrocar actuator (231), which is coupled to trocar (230), may actuatelongitudinally within and relative to driver actuator (64). Othercomponents may be disposed within driver actuator (64) as will beapparent to one of ordinary skill in the art in view of the teachingsherein.

In the present example, shaft assembly (60) is substantially straight.However, shaft assembly (60) may extend distally from actuator handleassembly (70) with a preformed bend. In some versions, the preformedbend is configured to facilitate positioning of stapling head assembly(200) within a patient's colon. Various suitable bend angles or radiithat may be used will be apparent to those of ordinary skill in the artin view of the teachings herein. In examples where shaft assembly (60)includes a preformed bend, actuator (231) may be coupled with trocar(230) via a flexible band portion (not shown). Flexible band portion(not shown) may extend from a distal end of actuator (231), locatedproximal to the preformed bend, to couple with trocar (230), locateddistal to the preformed bend. Flexible band portion (not shown) may bedimensioned to flex during translation along the longitudinal profile ofthe preformed bend of shaft assembly (60). In such cases, trocaractuator (231) may be slidably housed within actuator handle assembly(70), while trocar (230) is slidably housed within tubular casing (210).Flexible band portion (not shown) may be connected to both trocar (230)and actuator (231) via pins.

Shaft assembly (60) may be further constructed in accordance with atleast some of the teachings of U.S. Pat. Nos. 5,205,459; 5,271,544;5,275,322; 5,285,945; 5,292,053; 5,333,773; 5,350,104; 5,533,661; U.S.Pub. No. 2012/0292372; and/or U.S. Pub. No. 2015/0083773, thedisclosures of which are incorporated by reference herein; and/or inaccordance with other configurations as will be apparent to one ofordinary skill in the art in view of the teachings herein.

D. Exemplary Actuator Handle Assembly

Referring now to FIGS. 7A-8, actuator handle assembly (70) comprises abody (72), a trigger (74), a lockout feature (82), a trigger actuationassembly (84), and a trocar actuation assembly (90). Trigger (74) of thepresent example is pivotably mounted to body (72) and is coupled totrigger actuation assembly (84) such that rotation of trigger (74) froman unfired position (shown in FIG. 7A) to a fired position (shown inFIG. 7B) actuates driver actuator (64) described above. A spring (78) iscoupled to body (72) and trigger (74) to bias trigger (74) towards theunfired position. Lockout feature (82) is a pivotable member that iscoupled to body (72). In a first, locked position, as shown in FIG. 7A,lockout feature (82) is pivoted upwards and away from body (72) suchthat lockout feature (82) engages trigger (74) and mechanically resistsactuation of trigger (74) by a user. In a second, unlocked position,such as that shown in FIGS. 1 and 7B, lockout feature (82) is pivoteddownward such that trigger (74) may be actuated by the user.Accordingly, with lockout feature (82) in the second position, trigger(74) can engage a trigger actuation assembly (84) to fire instrument F.

As shown in FIGS. 7A-7B, trigger actuation assembly (84) of the presentexample comprises a slidable trigger carriage (86) engaged with aproximal end of driver actuator (64). Carriage (86) includes a set oftabs (88) on a proximal end of carriage (86) to retain and engage a pairof trigger arms (76) extending from trigger (74). Accordingly, whentrigger (74) is pivoted, carriage (86) is actuated longitudinally andtransfers the longitudinal motion to driver actuator (64). In theexample shown, carriage (86) is fixedly coupled to the proximal end ofdriver actuator (64), though this is merely optional. Indeed, in onemerely exemplary alternative, carriage (86) may simply abut driveractuator (64) while a distal spring (not shown) biases driver actuator(64) proximally relative to actuator handle assembly (70).

Trigger actuation assembly (84) may be further constructed in accordancewith at least some of the teachings of U.S. Pat. Nos. 5,205,459;5,271,544; 5,275,322; 5,285,945; 5,292,053; 5,333,773; 5,350,104;5,533,661; U.S. Pub. No. 2012/0292372; and/or U.S. Pub. No. 2015/0083773the disclosures of which are incorporated by reference herein; and/or inaccordance with other configurations as will be apparent to one ofordinary skill in the art in view of the teachings herein.

Body (72) also houses trocar actuation assembly (90) configured toactuate trocar (230) longitudinally in response to rotation ofadjustment knob (98). As best shown in FIGS. 7A-8, trocar actuationassembly (90) of the present example comprises adjustment knob (98), agrooved shank (94), and a sleeve (92). Grooved shank (94) of the presentexample is located at a proximal end of trocar actuator (231). In otherversions, grooved shank (94) and trocar actuator (231) may alternativelybe separate components that engage to transmit longitudinal movement.While grooved shank (94) is configured to translate within body (72),grooved shank (94) does not rotate within body (72). Adjustment knob(98) is rotatably supported by the proximal end of body (72) and isoperable to rotate sleeve (92), which is engaged with grooved shank (94)via an internal tab (not shown). Adjustment knob (98) also definesinternal threading (not shown) as will be described in greater detailbelow. Grooved shank (94) of the present example comprises a continuousgroove (96) formed in the outer surface of grooved shank (94).Accordingly, when adjustment knob (98) is rotated, the internal tab ofsleeve (92) rides within groove (96) and grooved shank (94) islongitudinally actuated relative to sleeve (92). Since grooved shank(94) is located at the proximal end of trocar actuator (231), rotatingadjustment knob (98) in a first direction advances trocar actuator (231)distally relative to actuator handle assembly (70). When trocar (230) iscoupled with anvil (40), anvil (40) also advances distally relative tostapling head assembly (200) thereby increasing the distance betweenproximal surface (50) of the anvil (40) and distally presented decksurface (222) of deck member (220), otherwise known as a gap distance d.By rotating adjustment knob (98) in the opposite direction, trocaractuator (231) is actuated proximally relative to actuator handleassembly (70) to reduce the gap distance d between anvil (40) andstapling head assembly (200) when trocar (230) is coupled with anvil(40). Thus, trocar actuation assembly (90) is operable to actuate trocar(230) in response to rotating adjustment knob (98). Other suitableconfigurations for trocar actuation assembly (90) will be apparent toone of ordinary skill in the art in view of the teachings herein.

Groove (96) of the present example comprises a plurality of differentportions (96A, 96B, 96C) that have a varying pitch or number of groovesper axial distance. The present groove (96) is divided into a distalportion (96A), a middle portion (96B) and a proximal portion (96C). Asshown in FIG. 5, distal portion (96A) comprises a fine pitch or a highnumber of grooves over a short axial length of grooved shank (94).Middle portion (96B) comprises a section with comparably coarser pitchor fewer grooves per axial length such that relatively few rotations arerequired for the internal tab of sleeve (92) to traverse along axialdistance. When anvil (40) is in an initial, distal position in relationto stapling head assembly (200) (as shown in FIG. 10A) the internal tabof sleeve (92) is positioned in middle portion (96B). Accordingly, thegap distance d may be quickly reduced through relatively few rotationsof adjustment knob (98) while the internal tab of sleeve (92) traversesmiddle portion (96B). Proximal portion (96C) of the present example issubstantially like distal portion (96A) and comprises a fine pitch or ahigh number of grooves over a short axial distance of grooved shank (94)such that many rotations are required to traverse the short axialdistance. Proximal portion (96C) of the present example is engaged bythe internal threading defined by knob (98) when anvil (40) issubstantially near to stapling head assembly (200) (as shown in FIG.10B), such that indicator bar (110) moves within indicator window (120)along scale (130) to indicate that the anvil gap is within a desiredoperating range, as will be described in more detail below. Accordingly,when grooved shank (94) reaches a proximal position where the proximalportion (96C) of groove (96) engages the internal threading of knob(98), each rotation of adjustment knob (98) may reduce the gap distanced by a relatively small amount to provide for fine tuning. The internaltab of sleeve (92) may be disengaged from groove (96) when proximalportion (96C) is engaged with the internal threading of knob (98).

Trocar actuation assembly (90) may be further constructed in accordancewith at least some of the teachings of U.S. Pat. Nos. 5,205,459;5,271,544; 5,275,322; 5,285,945; 5,292,053; 5,333,773; 5,350,104;5,533,661; and/or U.S. Pub. No. 2015/0083773 the disclosures of whichare incorporated by reference herein; and/or in accordance with otherconfigurations as will be apparent to one of ordinary skill in the artin view of the teachings herein.

As noted above, gap distance d corresponds to the distance between anvil(40) and stapling head assembly (200). When instrument (10) is insertedinto a patient, this gap distance d may not be easily viewable.Accordingly, a moveable indicator bar (110), shown in FIGS. 8-9, isprovided to be visible through an indicator window (120) positionedopposite to trigger (74). As will be described in greater detail below,indicator bar (110) is operable to move in response to rotation ofadjustment knob (98) such that the position of indicator bar (110) isrepresentative of the gap distanced. As shown in FIG. 9, indicatorwindow (120) further comprises a scale (130) which indicates that theanvil gap is within a desired operating range (e.g., a green coloredregion or “green zone”) and a corresponding staple compressionrepresentation at each end of scale (130). By way of example only, asshown in FIG. 9, a first staple image (132) depicts a large stapleheight while a second staple image (134) depicts a small staple height.Accordingly, a user can view the position of the coupled anvil (40)relative to the stapling head assembly (200) via indicator bar (110) andscale (130). The user may then adjust the positioning of anvil (40) viaadjustment knob (98) accordingly.

In the example shown in FIGS. 7A-8, a U-shaped clip (100) is attached toan intermediate portion of trocar actuator (231) located distally ofgrooved shank (94). In the present example, an extension of trocaractuator (231) engages a slot in the housing of handle assembly (70) toprevent trocar actuator (231) from rotating about its axis whenadjustment knob (98) is rotated.

Because trocar actuator (231) and trocar (230) are two separatecomponents joined together during assembly, a tolerance stack may occuronce trocar (230) and trocar actuator (231) are assembled and suitablyincorporated into instrument (10). To accommodate for this potentialtolerance stack, it may be necessary to calibrate the proper placementof trocar actuator (231) within instrument (10) such that indicator bar(110) may show a proper gap distance d during exemplary use. U-shapedclip (100) of the present example further includes an elongated slot(102) on each of its opposite sides for receiving an attachment member,such as a screw, bolt, pin, etc., to selectively adjust the longitudinalposition of elongated slot (102) of U-shaped clip (100) relative totrocar actuator (231) for purposes of calibrating indicator bar (110)relative to scale (130). In some versions, the attachment member (e.g.,screw, bolt, pin, etc.) engages with a portion of body (72) tosubstantially prevent trocar actuator (231) from rotating about its axiswhen adjustment knob (98) is rotated.

As shown in FIG. 8, actuator handle assembly (70) further includes anindicator bracket (140) configured to engage and pivot an indicator(104). Indicator bracket (140) of the present example is slidablerelative to body (72) along a pair of slots formed on body (72).Indicator bracket (140) comprises a rectangular plate (144), anindicator arm (146), and an angled flange (142). Angled flange (142) isformed at the proximal end of rectangular plate (144) and includes anaperture (not shown) to slidable mount onto trocar actuator (231) and/orgrooved shank (94). A coil spring (150) is interposed between flange(142) and a boss (152) to bias flange (142) against U-shaped clip (100).Accordingly, when U-shaped clip (100) actuates distally with trocaractuator (231) and/or grooved shank (94), coil spring (150) urgesindicator bracket (140) to travel distally with U-shaped clip (100). Inaddition, U-shaped clip (100) urges indicator bracket (140) proximallyrelative to boss (152) when trocar actuator (231) and/or grooved shank(94) translate proximally, thereby compressing coil spring (150). Insome versions, indicator bracket (140) may be fixedly attached to trocaractuator (231) and/or grooved shank (94).

In the present example, a portion of lockout feature (82) abuts asurface (141) of indicator bracket (140) when indicator bracket (140) isin a longitudinal position that does not correspond to when gap distanced is within a desired operating range (e.g., a green colored region or“green zone”). When gap distance d is within a desired operating range(e.g., a green colored region or “green zone”), indicator bracket (140)narrows to provide a pair of gaps (145) on either side of an indicatorarm (146) that permits lockout feature (82) to pivot, thereby releasingtrigger (74). Accordingly, lockout feature (82) and indicator bracket(140) can substantially prevent a user from releasing and operatingtrigger (74) until anvil (40) is in a predetermined operating range.Lockout feature (82) may be omitted entirely in some versions.

This operating range may be visually communicated to the user via anindicator bar (110) of an indicator (104) shown against a scale (130),described briefly above. At the distal end of indicator bracket (140) isa distally projecting indicator arm (146) which terminates at alaterally projecting finger (148) for controlling the movement ofindicator (104). Indicator arm (146) and finger (148), best shown inFIG. 5, are configured to engage a tab (106) of indicator (104) suchthat indicator (104) is pivoted when indicator bracket (140) is actuatedlongitudinally. In the present example, indicator (104) is pivotablycoupled to body (72) at a first end of indicator (104), though this ismerely optional and other pivot points for indicator (104) will beapparent to one of ordinary skill in the art in view of the teachingsherein. An indicator bar (110) is positioned on the second end ofindicator (104) such that indicator bar (110) moves in response to theactuation of indicator bracket (140). Accordingly, as discussed above,indicator bar (110) is displayed through an indicator window (120)against a scale (130) (shown in FIG. 6) to show the relative gapdistance d between proximal surface (50) of anvil (40) and distallypresented deck surface (222) of deck member (220).

Of course indicator bracket (140), indicator (104), and/or actuatorhandle assembly (70) may be further constructed in accordance with atleast some of the teachings of U.S. Pat. Nos. 5,205,459; 5,271,544;5,275,322; 5,285,945; 5,292,053; 5,333,773; 5,350,104; 5,533,661; and/orU.S. Pub. No. 2012/0292372; and/or U.S. Pub. No. 2015/0083773 thedisclosures of which are incorporated by reference herein; and/or inaccordance with other configurations as will be apparent to one ofordinary skill in the art in view of the teachings herein.

E. Exemplary Use of Circular Stapling Surgical Instrument

FIGS. 7A-7B and FIGS. 10A-10E show an exemplary use of circular staplingsurgical instrument (10) in accordance with the description above. Asmentioned above, anvil (40) may selectively couple with trocar (230)such that movement of trocar (230) relative to tubular casing (210) anddeck member (220) leads to movement of anvil (40) relative to tubularcasing (210) and deck member (220). With anvil (40) as a separatecomponent, it should be understood that anvil (40) may initially beinserted and secured to a portion of tissue (2) prior to being coupledwith trocar (230). By way of example only, anvil (40) may be insertedinto and secured to a first tubular portion of tissue (2) while staplinghead assembly (200) is inserted into and secured to a second tubularportion of tissue (2). For instance, the first tubular portion of tissue(2) may be sutured to or about a portion of anvil (40), and the secondtubular portion of tissue (2) may be sutured to or about trocar (230).

As shown in FIG. 10A, anvil (40) may then be coupled to trocar (230) inaccordance with the description above, such as a snap fitting betweenlatch members (30) of anvil (40) and head (234) of trocar (230). In FIG.10A, trocar (230) is shown in a distal most actuated position. Trocar(230) may be actuated to the distal most actuated position by rotationof knob (98) in accordance with the description above. Such an extendedposition for trocar (230) may provide a larger area to which tissue (2)may be coupled prior to attachment of anvil (40). The extended positionof trocar (230) may also provide for easier attachment of anvil (40) totrocar (230). At the position shown in FIG. 10A, trigger (74) is lockedin the position shown in FIG. 7A by lockout feature (82), as lockoutfeature (82) may not pivot to unlock trigger (74) due to interferencecaused by surface (141) of indicator bracket (140) in accordance withthe description above.

As mentioned above, when anvil (40) is coupled to trocar (230), rotationof adjustment knob (98) may translate both trocar (230) and anvil (40),thereby enlarging or reducing gap distanced. For instance, as shownsequentially in FIGS. 10A-10B, anvil (40) is shown actuating proximallyrelative to actuator handle assembly (70) from an initial, open position(FIG. 10A) to a closed position (FIG. 10B) where gap distance d isbrought within a suitable predetermined range. When gap distance d isbrought within a suitable predetermined range, indicator bar (110) maymove within indicator window (120) to show the relative gap distance dis within a desired operating range (e.g. a green colored region or“green zone”) in accordance with the description above. Additionally,shown between FIGS. 7A-7B, when gap distance d is brought within asuitable predetermined range, lockout feature (82) may be pivotedrelative to body (72) to an unlocked position and trigger (74) may pivotrelative to body (72) to engage trigger actuation assembly (84) inaccordance with the description above.

As shown in FIG. 7B, with lockout feature (82) pivoted into the unlockedposition, trigger (74) is pivoted toward body (72) such that triggerarms (76) drive against tabs (88) to distally actuate slidable triggercarriage (86) and driver actuator (64). As shown in FIG. 10C, distalactuation of driver actuator (64) drives slidable staple driver member(250), staples drivers (252), and cylindraceous knife member (240)distally. Distal advancement of staple drivers 9352) drive staples (66)against corresponding staple forming pockets (52) thereby staplingtissue (2) between anvil (40) and stapling head assembly (200) to form acontinuous tubular portion of tissue (2). Additionally, distaladvancement of cylindraceous knife member (240) severs excess tissuelocated radially interior to newly formed staples (66). Stapling headassembly (200) is operable to staple and sever tissue (2) by a userpivoting a trigger (74) of actuator handle assembly (70), as will bedescribed in greater detail below.

As best shown in FIG. 10D, once trigger (74) has been actuated to stapleand sever tissue (2), a user may then turn rotatable knob (98) todistally advance anvil (40), thereby releasing portions of tissue (2)grasped between proximal surface (50) of anvil (40) and distallypresented deck surface (222) of deck member (220). As best shown in FIG.10E, with previously grasped tissue (2) released, a user may then removeinstrument (10), thereby leaving a continuous tubular portion of tissue(2) behind.

II. Exemplary Alternative Circular Stapling Surgical Instrument

As described above, trigger (74) of instrument is pivotably mounted tobody (72), while a separate spring (78) is coupled to both body (72) andtrigger (74) in order to resiliently bias trigger (74) toward an unfiredposition. However, use of a separate spring (78) as a biasing mechanismbetween trigger (74) and body (72) may add to component and assemblycosts and take up an unnecessary amount of space within the interior ofbody (72). Therefore, it may be desirable to provide for a triggerhaving an integral resilient feature that directly interacts with a bodyof an instrument to bias the trigger toward an open position.

A. Overview of Exemplary Circular Stapling Surgical Instrument

FIGS. 12-13 show an exemplary circular stapling surgical instrument(310) that may be used in replacement of instrument (10) describedabove. Therefore, instrument (310) may perform substantially similarlyas instrument (10) describe above, with differences described below.Instrument (310) includes an anvil (320), a firing system (360), aclosure system (400), and a casing assembly (500). In brief, closuresystem (400) and anvil (320) are operable to clamp tissue between anvil(320) and a deck member (364) of firing system (360); while firingsystem (360) and anvil (40) are operable to cut and staple tissueclamped between anvil (320) and deck member (364). As will be describedin greater detail below, firing system (360) includes a trigger (370)having a lever (372) with an integrated leaf spring (374). As will alsobe described in greater detail below, trigger (370) having an integratedleaf spring (374) configured to bias trigger (370) to an opened positionmay reduce costs associated with components and assembly, as well assave space within the interior of casing assembly (500).

Anvil (320) is substantially like anvil (40) described above. Therefore,Anvil (320) includes a proximal shaft (324), an anvil head (328), and apair of pivoting latch members (334); which are substantially likeproximal shaft (44), anvil head (48), and pivoting latch members (30)described above, respectively. Therefore, proximal shaft (44) defines apair of lateral openings (322) and a bore (326), which are substantiallylike lateral openings (42) and bore (46) described above, respectively.Anvil head (328) includes a proximal surface (330) defining a pluralityof staple forming pockets (332); which are substantially like proximalsurface (50) and stapling forming pockets (52) described above.

Closure system (400) is substantially like closure system describedabove, with differences described below. FIGS. 14-15 show closure system(400) of instrument (310). A will be described in greater detail below,closure system (400) includes a monolithic closure rod (402) extendingfrom a proximal shank portion (420) to a distal trocar portion (410). Inbrief, monolithic closure rod (402) is configured to actuate relative tocasing assembly (500) in response to rotation or adjustment knob (460),selectively attach to anvil (320), and actuate anvil (320) to clamptissue between anvil (320) and deck member (364) prior to actuatingfiring system (360).

Closure system (400) includes monolithic closure rod (402), a gapindicator assembly (450), and an adjustment knob (460). Adjustment knob(460) is rotatably supported on a proximal end of casing assembly (500)such that adjustment knob (460) may rotate about its own longitudinalaxis while remaining longitudinally stationary relative to casingassembly (500). Adjustment knob (460) includes a sleeve (461), which issubstantially like sleeve (92) described above. As best seen in FIG. 15,adjustment knob (460) defines a distally open channel (464). Distallyopen channel (464) is dimensioned to slidably receive a proximal groovedsection (430) of monolithic closure rod (402). Adjustment knob (460)includes an internal tab (462) extending within distally open channel(464) as well as an internal threading portion (466); which may besubstantially similar internal tab and internal threading of adjustmentknob (98) described above, respectively. Therefore, like adjustment knob(98) and grooves (96A, 96B) described above, internal tab (462) may meshwith grooves (432A, 432B) of proximal grooved section (430) such thatrotation of internal tab (462) will actuate monolithic closure rod (402)relative to casing assembly (500). Additionally, like adjustment knob(98) and groove (96C) described above, internal threading (466) mayselectively engage with groove (432C) when monolithic closure rod istranslated proximal enough such that rotation of internal threading(466) may actuate monolithic closure rod (402) relative to casingassembly (500).

Gap indicator assembly (450) is configured to indicate through indicatorwindow (506) a gap distance d between anvil (320) and deck member (364)during exemplary use. Gap indicator assembly (450) includes a spring(451), an indicator bracket (440), a U-shaped clip (458), and anindicator (452); which are substantially like spring (150), indicatorbracket (140), U-shaped clip (100), and indicator (104) described above,respectively. Therefore, indicator bracket (140) includes an angledflange (442), a rectangular plate (444) having a surface (441), anindicator arm (446) defining gaps (445), and a laterally projectingfinger (448); which are substantially like angled flange (142),rectangular plate (144) having surface (141), indicator arm (146)defining gaps (145), and laterally projecting finger (148) describedabove. Additionally, indicator (452) is pivotally mounted to casingassembly (500). Indicator (452) includes a tab (454), and an indicatorbar (456); which are substantially like tab (106) and indicator bar(110) described above.

Like spring (150), U-shaped clip (100), and indicator bracket (140)described above, spring (451) biases angled flange (442) againstU-shaped clip (458) while U-shaped clip (458) is attached to monolithicclosure rod (402) via pin (455). Angled flange (442) is formed at theproximal end of rectangular plate (444) and includes an aperture toslidable mount onto monolithic closure rod (402). Therefore, asmonolithic closure rod (402) is actuated distally, spring (451) willbias angled flange (442) distally to remain in engagement with U-shapedclip (458). Conversely, when monolithic closure rod (402) is actuatedproximally, U-shaped clip (458) will push angled flange (442) furtherproximally, thereby compressing spring (451). In other words, spring(451) and U-shaped clip (458) interact with angled flange (442) suchthat indicator bracket (440) actuates with monolithic closure rod (402).In the present example, indicator bracket (440) is slidably attached tocasing assembly (500). However, in some versions, indicator bracket(440) may be fixedly attached to monolithic closure rod (402).

In the present example, a portion of lockout feature (371) abuts asurface (441) of indicator bracket (440) when indicator bracket (440) isin a longitudinal position that does not correspond to when gap distanced is within a desired operating range (e.g., a green colored region or“green zone”). When gap distance d is within a desired operating range(e.g., a green colored region or “green zone”), indicator bracket (440)narrows to provide a pair of gaps (445) on either side of an indicatorarm (446) that permits lockout feature (371) to pivot, thereby unlockingtrigger (370). Accordingly, lockout feature (371) and indicator bracket(440) can substantially prevent a user from unlocking and operatingtrigger (370) until anvil (320) is in a predetermined operating range.Lockout feature (371) may be omitted entirely in some versions.

This operating range may be visually communicated to the user viaindicator bar (456) of indicator (452) shown against a scale (not shown)of indicator window (506), described briefly above. At the distal end ofindicator bracket (440) is a distally projecting indicator arm (146)which terminates at a laterally projecting finger (448) for controllingthe movement of indicator (452). Indicator arm (446) and finger (448)are configured to engage tab (454) of indicator (452) such thatindicator (452) is pivoted when indicator bracket (440) is actuatedlongitudinally. In the present example, indicator (452) is pivotablycoupled to casing assembly (500) at a first end of indicator (452),though this is merely optional and other pivot points for indicator(452) will be apparent to one of ordinary skill in the art in view ofthe teachings herein. Indicator bar (456) is positioned on the secondend of indicator (452) such that indicator bar (456) moves in responseto the actuation of indicator bracket (440). Accordingly, like indicatorbar (110) described above, indicator bar (456) is displayed through anindicator window (506) against a scale (not shown) to show the relativegap distance d between proximal surface (330) of anvil (320) anddistally presented deck surface of deck member (364).

As best seen in FIGS. 14-15, monolithic closure rod (402) includesproximal shank portion (420), a connecting band portion (404), anddistal trocar portion (410). Distal trocar portion (410) includes ashaft (412) and a head (414), which may be substantially like shaft(232) and head (234) of trocar (230) described above. Distal trocarportion (410) is slidably housed within inner core member (not shown) oftubular casing (512). Distal trocar portion (410) may interact withanvil (320) in a substantially similar manner as trocar (230) and anvil(40), described above. Head (414) includes a pointed tip (416) and aninwardly extending proximal surface (418). Shaft (412) thus provides areduced outer diameter just proximal to head (414), with surface (418)providing a transition between the reduced outer diameter of shaft (412)and the outer diameter of head (414). While tip (416) is pointed in thepresent example, tip (416) is not sharp. Tip (416) will thus not easilycause trauma to tissue due to inadvertent contact with tissue. Head(414) and the distal portion of shaft (412) are configured for insertionin bore (326) of anvil (320). Proximal surface (418) and latch shelves(not shown) have complementary positions and configurations such thatlatch shelves (not shown) engage proximal surface (418) when proximalshaft (324) of anvil (320) is fully seated on distal trocar portion(410). Anvil (320) may thus secure to distal trocar portion (410)through a snap fitting between latch members (334) and head (414). Inaddition, or in the alternative, distal trocar portion (410) may includea magnetic portion (not shown) which may attract anvil (320) towardsdistal trocar portion (410). Still further configurations andarrangements for anvil (320) and distal trocar portion (410) will beapparent to one of ordinary skill in the art in view of the teachingsherein.

Proximal shank portion (420) includes proximal grooved section (430) anda rod (422). Proximal shank portion (420) is slidably housed withinhandle portion (502) of casing assembly (500). Rod (422) defines a pinhole (428) that receives pin (455). As mentioned above, pin (455)couples U-shaped clip (458) of gap indicator assembly (450) to rod(422). Additionally, a portion of pin (455) may be slidably housedwithin a slot defined by casing assembly (500) such that rod (422), andtherefore the rest of monolithic closure rod (402) is rotationallyconstrained about the longitudinal axis defined by monolithic closurerod (402), but also such that monolithic closure rode (402) maytranslate relative to casing assembly (500).

Proximal grooved section (430) of the present example comprises acontinuous groove (432) formed in the outer surface of proximal groovedsection (430). Accordingly, when adjustment knob (460) is rotated,internal tab (462) rides within continuous groove (432) and monolithicclosure rod (402) is longitudinally actuated relative to adjustment knob(460). Rotating adjustment knob (460) in a first direction advancesmonolithic closure rod (402) distally relative to casing assembly (500).When distal trocar portion (410) is coupled with anvil (320), anvil(320) also advances distally relative to tubular casing (512) of casingassembly (500) thereby increasing the distance between proximal surface(330) of the anvil (320) and distally presented deck surface of deckmember (364), otherwise known as gap distance d. By rotating adjustmentknob (460) in the opposite direction, monolithic closure rod (402) isactuated proximally relative to casing assembly (500) to reduce the gapdistance d between anvil (320) and deck member (364) when distal trocarportion (410) is coupled with anvil (320). Thus, closure system (400) isoperable to actuate monolithic closure rod (402) in response to rotatingadjustment knob (460). Other configurations for closure system (400)will be apparent to one of ordinary skill in the art in view of theteachings herein.

Continuous groove (432) of the present example comprises a plurality ofdifferent portions (432A, 432B, 432C) that have a varying pitch ornumber of grooves per axial distance. The present groove (432) isdivided into a distal portion (432A), a middle portion (432B), and aproximal portion (432C). Distal portion (432A) comprises a fine pitch ora high number of grooves over a short axial length of proximal groovedsection (430). Middle portion (432B) comprises a section with comparablycoarser pitch or fewer grooves per axial length such that relatively fewrotations are required for the internal tab (462) of adjustment knob(460) to traverse along axial distance. When anvil (320) is in aninitial, distal position in relation to tubular casing (512), theinternal tab (462) of knob (460) is positioned in middle portion (432B).Accordingly, the gap distance d may be quickly reduced throughrelatively few rotations of adjustment knob (460) while the internal tab(462) traverses middle portion (432B).

Proximal portion (432C) of the present example is substantially likedistal portion (432A) and comprises a fine pitch or a high number ofgrooves over a short axial distance of proximal grooved section (430)such that many rotations are required to traverse the short axialdistance. Proximal portion (432C) of the present example is engaged bythe internal proximal threading (466) defined by knob (460) when anvil(320) is substantially near deck member (364), such that indicator bar(456) moves within indicator window (506) along scale (not shown) toindicate that the anvil gap is within a desired operating range.Accordingly, when grooved proximal grooved section (430) reaches aproximal position where the proximal portion (432C) of groove (432)engages the internal proximal threading (466) of knob (460), eachrotation of adjustment knob (460) may reduce the gap distance d by arelatively small amount to provide for fine tuning.

Connecting band portion (404) extends between proximal shank portion(420) and distal trocar portion (410) to connect a distal end of rod(422) and a proximal end of shaft (412). Connecting band portion (404)is sufficiently flexible to actuate along the longitudinal profile ofpreformed bent shaft portion (504) of casing assembly (500).

Casing assembly (500) forms a mechanical ground for the firing system(360) and closure system (400). Casing assembly (500) includes a firstportion (510) and a second portion (560) configured to couple with eachother to house portions or firing system (360) and closure system (400).Unlike instrument (10), casing assembly (500) forms a handle portion(502), a preformed bent shaft portion (504), and a tubular casing (512).Similar to shaft assembly (60), preformed bent shaft portion (504)slidably houses a portion of closure system (400) and firing system(360). Unlike shaft assembly (60), preformed bent shaft portion (504)includes a preformed bend.

Like tubular casing (210) described above, tubular casing (512) alsoincludes cylindraceous inner core member (not shown) that slidablereceives a trocar portion (410) of closure system (400). When coupledtogether, first portion (510) and second portion (560) defines anindicator window (506) and a proximal opening (508). Similar toindicator window (120) described above, indicator window (506) has ascale (now shown) and is dimensioned such that an operator may viewindicator bar (110) against scale (not shown) in order to determine gapdistance d. Additionally, when coupled together, first portion (510) andsecond portion (560) define a proximal opening (508), which rotatablysupports adjustment knob (460) of closure system (400).

B. Exemplary Firing System Having Trigger with Integrated ResilientMember

Firing system (360) is substantially like firing system described above,with differences described below. Therefore, firing system (360)includes a trigger (370), a slidable trigger carriage (367), a driveractuator (365), a slidable staple driver member (362) defining a bore(366), a cylindraceous knife member (363), and a deck member (364);which are substantially like trigger (74), slidable trigger carriage(86), driver actuator (64), slidable staple driver member (250) defininga bore (254), cylindraceous knife member (240), and deck member (220)described above, respectively, with differences described below.

As will be described in greater detail below, trigger (370) is operableto actuate slidable trigger carriage (367), driver actuator (365),slidable staple driver member (362), and cylindraceous knife member(363) to thereby simultaneously staple and sever tissue between anvil(320) and deck member (364). Like driver actuator (64) described above,driver actuator (365) comprises a tubular member having an openlongitudinally extending channel such that adjacent portions ofmonolithic closure rod (402) may actuate longitudinally within andrelative to driver actuator (365).

Slidable staple driver member (362) includes a plurality of stapledrivers (368), which are substantially like staple drivers (252)described above. Deck member (364) houses a plurality of staples withinstaple pockets (not shown) that align with respective staple drivers(368). Staple drivers (368) are configured to drive staples from staplepockets of deck member (364), through an annular array of stapleopenings (not shown) of deck member (368), and against a plurality ofstaple forming pockets (332) of anvil (320), in accordance with theprinciples described above. Like cylindraceous knife member (240),cylindraceous knife member (363) is coupled with slidable staple drivermember (362) to actuate with slidable staple driver member (362) tosever excess tissue radially interior to newly formed staples, inaccordance with the principles described above.

FIGS. 16-19 show trigger (370) of the present example in greater detail.Trigger (370) extends from distal portion (380) to a proximal portion(382). Trigger (370) includes a lever (372) and an integral leaf spring(374) extending distally from lever (372). Lever (372) includes a pairof side walls (378) connected to each other with a bottom wall (379).Each side wall (378) includes a tab (376) and a lockout interface (386).Additionally, each side wall (378) also defines a pivot hole (375).Pivot holes (375) are dimensioned to receive a pivot boss (514) of firstportion (500) of casing assembly (500), thereby pivotally couplingtrigger (370) with casing assembly (500). Trigger (370) is pivotablycoupled with casing assembly (500) and is configured to pivot relativeto casing assembly (500) from an opened position to a closed position toactuate slidable staple driver member (362) and cylindraceous knifemember (363) to staple and sever tissue captured between anvil (320) anddeck member (364) during exemplary use.

Tabs (376) of the present example are operable like tabs (88) describedabove. Therefore, tabs (376) are configured to interact with slidabletrigger carriage (367) when trigger (370) is pivoted from the openedposition to the closed position in order distally actuate triggercarriage (367). Trigger carriage (367) is coupled with driver actuator(365) such that movement of trigger carriage (367) causes movement ofslidable staple driver member (362), and cylindraceous knife member(363), in accordance with the principle described above.

Lockout interface (386) is dimensioned to interact with lockout features(371) such that lockout feature (371) may prevent pivoting of trigger(370), like trigger (74) and lockout feature (82) described above.Alternatively, lockout interface (386) may be dimensioned to replacelockout feature (371) all together, such that lockout interface (386)may abut against surface (441) of indicator bracket (440) to preventaccidental firing of trigger (370) when anvil (320) is not within thedesired operating range (e.g., a green colored region or “green zone”).

As best seen in FIGS. 16 and 18, integral leaf spring (374) extends frombottom wall (379), along the distal profile of side walls (378), anddistally from the rest of trigger (370). The portion of leaf spring(374) extending along the distal profile of side walls (378) defines arespective gap (384) with each side wall (378). Therefore, leaf spring(374) has a width smaller than the lateral distance between side walls(378). This may allow leaf spring (374) to pivot and/or otherwise moverelative to within the cavity defined by both side walls (378) andbottom wall (379).

The portion of leaf spring (374) extending distally from side wall (378)is dimensioned to be housed within a spring channel (518) defined byinternal ribbing (516) of handle assembly (500). Integral leaf spring(374) is sufficiently resilient and dimensioned to bias trigger (370)toward an open position. Specifically, as shown between FIGS. 21A-21C,integral leaf spring (374) may resiliently bend or flex from a naturalposition associated with trigger (370) in an open position (as shown inFIG. 21A), toward a flexed position associated with trigger (370) in theclosed position (as shown in FIG. 21B), in response to an operatorpivoting trigger (370). Once an operator releases trigger (370) (asshown in FIG. 21C), integral leaf spring (374) may resiliently return toits natural position, thereby abutting against internal ribs (516) topivot trigger (370) back to the opened position.

Trigger (370) may be formed from a single piece of material (i.e., suchthat the entirety of trigger (370) consists of a homogenous continuum ofmaterial), and integral leaf spring (374) may be stamped and bent fromthat same single piece of material to provide the desired geometricshape relative to the rest of trigger (370). Trigger (370) may be formedwith any suitable material having any suitable thickness that would beapparent to one having ordinary skill in the art in view of theteachings herein. For example, trigger (370) may be formed out of sheetmetal having an initial thickness of about 0.040 inches. Becauseintegral leaf spring (374) is formed unitarily with the rest of trigger(370), assembly may be simplified while part costs may be reduced.

III. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. The following examplesare not intended to restrict the coverage of any claims that may bepresented at any time in this application or in subsequent filings ofthis application. No disclaimer is intended. The following examples arebeing provided for nothing more than merely illustrative purposes. It iscontemplated that the various teachings herein may be arranged andapplied in numerous other ways. It is also contemplated that somevariations may omit certain features referred to in the below examples.Therefore, none of the aspects or features referred to below should bedeemed critical unless otherwise explicitly indicated as such at a laterdate by the inventors or by a successor in interest to the inventors. Ifany claims are presented in this application or in subsequent filingsrelated to this application that include additional features beyondthose referred to below, those additional features shall not be presumedto have been added for any reason relating to patentability.

Example 1

An apparatus, comprising: (a) a body assembly comprising: (i) a handleportion, wherein the handle portion comprises a pivot boss and a pair ofinternal ribs defining a spring channel, and (ii) a shaft portionextending distally from the handle portion; (b) an end effectorcomprising a staple driver, wherein the staple driver is operable toactuate relative to the shaft portion of the body between an unfiredposition and a fired position; and (c) a firing assembly comprising: (i)a driver actuator configured to actuate the staple driver between theunfired position and the fired position, wherein the driver actuator isin communication with the staple driver, wherein the driver actuator isslidably housed within the shaft portion, and (ii) a trigger comprisinga lever and an integral spring member, wherein the lever is pivotallycoupled to the handle portion via the pivot boss, wherein the trigger isconfigured to pivot between a first position and a second position toslide the driver actuator within the shaft portion, wherein the firstposition is associated with the staple driver in the unfired position,wherein the second position is associated with the staple driver in thefired position, wherein the integral spring member is at least partiallyhoused within the spring channel of the handle portion, wherein theintegral spring member is configured to resiliently bias the triggertoward the first position.

Example 2

The apparatus of Example 1, wherein the lever further comprises a firstside wall defining a first pivot hole and a second side wall defining asecond pivot hole, wherein the pivot boss extends through the firstpivot hole and the second pivot hole.

Example 3

The apparatus of Example 2, wherein the lever further comprises a bottomwall, wherein the integral spring member extends from the bottom wall ofthe lever.

Example 4

The apparatus of any one or more of Examples 1 through 3, wherein theintegral spring member comprises a leaf spring.

Example 5

The apparatus of Example 4, wherein the lever and the integral springmember are formed from a single piece of sheet metal such that the leverand the integral spring member consist of a homogenous continuum ofmaterial.

Example 6

The apparatus of Example 5, wherein the single piece of sheet metal hasa thickness of 0.040 inches.

Example 7

The apparatus of any one or more of Examples 1 through 6, wherein thelever comprises a pair of tabs configured to communicate motion to thedriver actuator.

Example 8

The apparatus of any one or more of Examples 1 through 7, furthercomprising an anvil and a closure system, wherein the closure system isconfigured to selectively couple with the anvil and actuate the anvilrelative to the end effector.

Example 9

The apparatus of Example 8, wherein the closure system further comprisesa gap indicator assembly, wherein the gap indicator assembly isconfigured to prevent the trigger from pivoting to the second positionwhen the anvil is out of a predetermined operating range relative to theend effector, wherein the gap indicator assembly is configured to allowthe trigger to pivot to the second position when the anvil is within thepredetermined operating range relative to the end effector.

Example 10

The apparatus of Example 9, wherein the gap indicator assembly comprisesan indicator bracket within the handle assembly, wherein the triggercomprises a lockout interface, wherein the indicator bracket inconfigured to directly abut against the lockout interface when the anvilis out of the predetermined operating range relative to the endeffector.

Example 11

The apparatus of any one or more of Examples 8 through 10, wherein theclosure system further comprises a rotary knob attached to the bodyassembly and a trocar slidably housed within the body assembly, whereinthe rotary knob is configured to rotate in order to slide the trocarrelative to the body assembly.

Example 12

The apparatus of any one or more of Examples 1 through 11, wherein theintegral spring extends distally relative to the lever.

Example 13

The apparatus of any one or more of Examples 1 through 12, wherein theend effector further comprises a cylindrical knife member coupled withthe staple driver.

Example 14

The apparatus of any one or more of Examples 1 through 13, furthercomprising an slidable trigger carriage attached to the trigger and thedriver actuator.

Example 15

The apparatus of any one or more of Examples 1 through 14, wherein theshaft portion comprises a pre-formed bend.

Example 16

An apparatus, comprising: (a) a body assembly comprising a handleportion; (b) an end effector comprising a staple driver, wherein thestaple driver is operable to actuate relative to the body assemblybetween an unfired position and a fired position; and (c) a triggercomprising a lever and an integral spring member extending unitarilyfrom the lever, wherein the lever is pivotally coupled to the handleportion, wherein the trigger is configured to pivot between a firstposition and a second position to slidably actuate the staple driver,wherein the first position is associated with the staple driver in theunfired position, wherein the second position is associated with thestaple driver in the fired position, wherein the integral spring memberis housed within the body assembly, wherein the integral spring memberis configured to resiliently bias the trigger relative to the bodyassembly toward the first position.

Example 17

The apparatus of Example 16, wherein the lever comprises a first sidewall and a second side wall defining a gap, wherein the integral springmember has a first portion extending within the gap of the first sidewall and the second side wall.

Example 18

The apparatus of Example 17, wherein the integral spring comprise asecond portion that abuts against an internal rib of the body assembly.

Example 19

An apparatus, comprising: (a) a body assembly comprising: (i) a handleportion, (ii) a shaft portion extending distally from the handleportion; (b) an end effector comprising a staple driver, wherein thestaple driver is operable to actuate relative to the shaft portion ofthe body between an unfired position and a fired position; and (c) atrigger configured to pivot between a first position and a secondposition to actuate the staple driver, wherein the first position isassociated with the staple driver in the unfired position, wherein thesecond position is associated with the staple driver in the firedposition wherein the trigger is made from a single piece of sheet metalsuch that the trigger consists of a homogenous continuum of material,wherein the trigger comprises: (i) a lever pivotally coupled to thehandle portion, and (ii) an integral spring member, wherein the integralspring member is configured to resiliently bias the trigger toward thefirst position.

Example 20

The apparatus of Example 19, wherein the handle portion of the bodyassembly houses a portion of the integral spring member.

IV. Miscellaneous

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

At least some of the teachings herein may be readily combined with oneor more teachings of U.S. Pat. No. 7,794,475, entitled “Surgical StaplesHaving Compressible or Crushable Members for Securing Tissue Therein andStapling Instruments for Deploying the Same,” issued Sep. 14, 2010, thedisclosure of which is incorporated by reference herein; U.S. patentapplication Ser. No. 13/693,430, entitled “Trans-Oral Circular AnvilIntroduction System with Dilation Feature,” filed Dec. 4, 2012, thedisclosure of which is incorporated by reference herein; U.S. patentapplication Ser. No. 13/688,951, entitled “Surgical Staple with IntegralPledget for Tip Deflection,” filed Nov. 29, 2012, the disclosure ofwhich is incorporated by reference herein; U.S. patent application Ser.No. 13/706,827, entitled “Surgical Stapler with Varying Staple Widthsalong Different Circumferences,” filed Dec. 6, 2012, the disclosure ofwhich is incorporated by reference herein; U.S. patent application Ser.No. 13/688,992, entitled “Pivoting Anvil for Surgical Circular Stapler,”filed Nov. 29, 2012, the disclosure of which is incorporated byreference herein; U.S. patent application Ser. No. 13/693,455, entitled“Circular Anvil Introduction System with Alignment Feature,” filed Dec.4, 2012, the disclosure of which is incorporated by reference herein;U.S. patent application Ser. No. 13/716,313, entitled “Circular Staplerwith Selectable Motorized and Manual Control, Including a Control Ring,”filed Dec. 17, 2012, the disclosure of which is incorporated byreference herein; U.S. patent application Ser. No. 13/716,318, entitled“Motor Driven Rotary Input Circular Stapler with Modular End Effector,”filed Dec. 17, 2012, the disclosure of which is incorporated byreference herein; and/or U.S. patent application Ser. No. 13/176,323,entitled “Motor Driven Rotary Input Circular Stapler with LockableFlexible Shaft,” filed Dec. 17, 2012, the disclosure of which isincorporated by reference herein. Various suitable ways in which suchteachings may be combined will be apparent to those of ordinary skill inthe art.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices described above may have application inconventional medical treatments and procedures conducted by a medicalprofessional, as well as application in robotic-assisted medicaltreatments and procedures. By way of example only, various teachingsherein may be readily incorporated into a robotic surgical system suchas the DAVINCI™ system by Intuitive Surgical, Inc., of Sunnyvale, Calif.

Versions described above may be designed to be disposed of after asingle use, or they can be designed to be used multiple times. Versionsmay, in either or both cases, be reconditioned for reuse after at leastone use. Reconditioning may include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, someversions of the device may be disassembled, and any number of theparticular pieces or parts of the device may be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, some versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a operatorimmediately prior to a procedure. Those skilled in the art willappreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. An apparatus, comprising: (a) a body assembly comprising:(i) a handle portion, wherein the handle portion comprises a pivot bossand a pair of internal ribs defining a spring channel, and (ii) a shaftportion extending distally from the handle portion; (b) an end effectorcomprising a staple driver, wherein the staple driver is operable toactuate relative to the shaft portion of the body between an unfiredposition and a fired position; and (c) a firing assembly comprising: (i)a driver actuator configured to actuate the staple driver between theunfired position and the fired position, wherein the driver actuator isin communication with the staple driver, wherein the driver actuator isslidably housed within the shaft portion, and (ii) a trigger comprisinga lever and an integral spring member, wherein the lever is pivotallycoupled to the handle portion via the pivot boss, wherein the trigger isconfigured to pivot between a first position and a second position toslide the driver actuator within the shaft portion, wherein the firstposition is associated with the staple driver in the unfired position,wherein the second position is associated with the staple driver in thefired position, wherein the integral spring member is at least partiallyhoused within the spring channel of the handle portion, wherein theintegral spring member is configured to resiliently bias the triggertoward the first position.
 2. The apparatus of claim 1, wherein thelever further comprises a first side wall defining a first pivot holeand a second side wall defining a second pivot hole, wherein the pivotboss extends through the first pivot hole and the second pivot hole. 3.The apparatus of claim 2, wherein the lever further comprises a bottomwall, wherein the integral spring member extends from the bottom wall ofthe lever.
 4. The apparatus of claim 1, wherein the integral springmember comprises a leaf spring.
 5. The apparatus of claim 4, wherein thelever and the integral spring member are formed from a single piece ofsheet metal such that the lever and the integral spring member consistof a homogenous continuum of material.
 6. The apparatus of claim 5,wherein the single piece of sheet metal has a thickness of 0.040 inches.7. The apparatus of claim 1, wherein the lever comprises a pair of tabsconfigured to communicate motion to the driver actuator.
 8. Theapparatus of claim 1, further comprising an anvil and a closure system,wherein the closure system is configured to selectively couple with theanvil and actuate the anvil relative to the end effector.
 9. Theapparatus of claim 8, wherein the closure system further comprises a gapindicator assembly, wherein the gap indicator assembly is configured toprevent the trigger from pivoting to the second position when the anvilis out of a predetermined operating range relative to the end effector,wherein the gap indicator assembly is configured to allow the trigger topivot to the second position when the anvil is within the predeterminedoperating range relative to the end effector.
 10. The apparatus of claim9, wherein the gap indicator assembly comprises an indicator bracketwithin the handle assembly, wherein the trigger comprises a lockoutinterface, wherein the indicator bracket in configured to directly abutagainst the lockout interface when the anvil is out of the predeterminedoperating range relative to the end effector.
 11. The apparatus of claim8, wherein the closure system further comprises a rotary knob attachedto the body assembly and a trocar slidably housed within the bodyassembly, wherein the rotary knob is configured to rotate in order toslide the trocar relative to the body assembly.
 12. The apparatus ofclaim 1, wherein the integral spring extends distally relative to thelever.
 13. The apparatus of claim 1, wherein the end effector furthercomprises a cylindrical knife member coupled with the staple driver. 14.The apparatus of claim 1, further comprising an slidable triggercarriage attached to the trigger and the driver actuator.
 15. Theapparatus of claim 1, wherein the shaft portion comprises a pre-formedbend.
 16. An apparatus, comprising: (a) a body assembly comprising ahandle portion; (b) an end effector comprising a staple driver, whereinthe staple driver is operable to actuate relative to the body assemblybetween an unfired position and a fired position; and (c) a triggercomprising a lever and an integral spring member extending unitarilyfrom the lever, wherein the lever is pivotally coupled to the handleportion, wherein the trigger is configured to pivot between a firstposition and a second position to slidably actuate the staple driver,wherein the first position is associated with the staple driver in theunfired position, wherein the second position is associated with thestaple driver in the fired position, wherein the integral spring memberis housed within the body assembly, wherein the integral spring memberis configured to resiliently bias the trigger relative to the bodyassembly toward the first position.
 17. The apparatus of claim 16,wherein the lever comprises a first side wall and a second side walldefining a gap, wherein the integral spring member has a first portionextending within the gap of the first side wall and the second sidewall.
 18. The apparatus of claim 17, wherein the integral springcomprise a second portion that abuts against an internal rib of the bodyassembly.
 19. An apparatus, comprising: (a) a body assembly comprising:(i) a handle portion, (ii) a shaft portion extending distally from thehandle portion; (b) an end effector comprising a staple driver, whereinthe staple driver is operable to actuate relative to the shaft portionof the body between an unfired position and a fired position; and (c) atrigger configured to pivot between a first position and a secondposition to actuate the staple driver, wherein the first position isassociated with the staple driver in the unfired position, wherein thesecond position is associated with the staple driver in the firedposition wherein the trigger is made from a single piece of sheet metalsuch that the trigger consists of a homogenous continuum of material,wherein the trigger comprises: (i) a lever pivotally coupled to thehandle portion, and (ii) an integral spring member, wherein the integralspring member is configured to resiliently bias the trigger toward thefirst position.
 20. The apparatus of claim 19, wherein the handleportion of the body assembly houses a portion of the integral springmember.